| Primary Device ID | 00841436108621 |
| NIH Device Record Key | b7f7611f-96cb-41a5-b158-38d435ecdfa9 |
| Commercial Distribution Discontinuation | 2019-01-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | System Drape |
| Version Model Number | DR-000537 |
| Catalog Number | DR-000537 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Width | 45.7 Centimeter |
| Length | 73.7 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436108621 [Package] Contains: 10841436108628 Package: [10 Units] Discontinued: 2019-01-16 Not in Commercial Distribution |
| GS1 | 10841436108628 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-03 |
| Device Publish Date | 2017-08-22 |
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| 00841436108621 | Sterile polyethylene instrument drape for use with NeuWave Certus 140 PDM |
| 00841436101417 | Sterile (76 x 76cm) polyethylene drape |
| 00841436110426 | Sterile (81 x 91cm) polyethylene drape |
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| 00841436104029 | Sterile (11.9 tapered to 4.9 x 55.6cm) CIV-Flex™ cover for use with Mammotome EX and SenoRX En |